Trial initiation follows completion of successful Phase 2 cohort, which met primary endpoints
BOSTON--(BUSINESS WIRE)--Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and drugs for optical surgical navigation, announced today that it has initiated the Phase 3 portion of its pivotal study evaluating the investigational ZW800-1 (nizaracianine triflutate) to highlight the ureter during abdominopelvic surgery.
“As the first zwitterionic near infrared (NIR) fluorophore, ZW800-1 represents an important advancement in enhanced surgical imaging. The first portion of this pivotal study found that strong visual contrast enhancement of the ureters provided apparent benefit to both patient and surgeon without compromising safety,” said John V. Frangioni, M.D., Ph.D., Curadel Founder and CEO. “With confidence in our target dose, we look forward to expanding the trial to eight sites worldwide with more than 50 surgeons. Our goal is to demonstrate for the first time that surgeons can assess ureter anatomy, function, and intactness in real time during open, laparoscopic, and robotic surgeries.”
ZW800-1 is a novel small molecule drug with a unique zwitterionic chemical structure that prevents the drug from binding non-specifically to tissues and organs after injection, and facilitates its elimination by the kidneys into urine. Once in urine, the drug creates visual contrast in the ureters that would otherwise not exist, and using a near-infrared (NIR) camera, surgeons can find the ureters and assess their function in real-time.
The Phase 3 portion of the trial has been approved for enrollment based on positive Phase 2 study findings. During Phase 2, ZW800-1 met its composite primary endpoint of a strong signal-to-background ratio and visualization of the required length of ureter(s), all with a favorable safety profile. There were no severe adverse events associated with the study drug. An optimal dose of only 2.5 mg will be utilized in the Phase 3 cohort, which expects to enroll more than 300 participants worldwide. More information on the trial can be found at clinicaltrials.gov (NCT06101745).
About Curadel Pharma
Curadel Pharma, based in Boston, Mass., is an audacious innovator aiming to prevent tumor resistance via disruptive zwitterionic radiopharma technology. Its novel, pan-tumor platform prevents tumor regrowth and resistance while eliminating collateral damage to healthy tissues. Curadel’s lead candidate, CPI-003, represents a potential best-in-class zwitterionic targeted alpha therapy (TAT) initially focused on the treatment of challenging rare cancers. The company is also developing image-guided surgical drugs. Its late-stage drug for ureter imaging is currently under evaluation in a pivotal trial. For more information, visit www.curadelpharma.com or visit us on LinkedIn.
Contacts
Kellie Hotz
kehotz@curadel.com
